A Phase 1 interventional study of Vilaprisan, BAY1002670 and Ulipristal in Leiomyoma, sponsored by Bayer. Terminated at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-06.
Sponsored by Bayer · Phase 1, Interventional, and Other
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 12 studies testing vilaprisan in Leiomyoma — none open to participants now, none under way, none of them phase 3. vilaprisan · Leiomyoma.
Among the 12 studies testing vilaprisan in Leiomyoma, this one is the 11th largest by enrollment, is one of 4 that started in 2017, is one of 4 in phase 1, and was the 7th registered.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
Browse Leiomyoma studies →None of the 12 studies testing vilaprisan in Leiomyoma is open now. The open studies under Leiomyoma, anywhere →
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 43 Leiomyoma studies recruiting now, 21 (49%) set no upper age limit and 21 (49%) stop at 75 or younger; 3 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 4 started in 2017.
This study's enrollment of 10 is below the median of 66 across 306 interventional studies indexed under Leiomyoma.
Median enrollment 98 across the 12 interventional studies. Of the 11 that completed or were terminated, 4 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 12 have an industry lead sponsor. The 1 most frequent:
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
12 studies in Leiomyoma by Bayer: none open now, none under way, none of them phase 3. Of 11 finished, 4 (36%) have results posted.
Among the 12 studies in Leiomyoma by Bayer, this one is the 11th largest by enrollment, is one of 4 that started in 2017, is one of 4 in phase 1, and was the 7th registered.
Bayer’s Leiomyoma studies by the year they started, since 2011.
None of the studies under way reaches primary completion within a year.
Among the 12 studies testing vilaprisan in Leiomyoma, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Bayer’s 12 in Leiomyoma:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
To investigate the clinical effects of vilaprisan and ulipristal acetate at molecular and cellular level on uterine and fibroid tissue taken from patients (after surgery / biopsy)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vilaprisan 2 mg oral daily over 8-12 weeks
Drug: Vilaprisan, BAY1002670
Ulipristal 5 mg oral daily over 8-12 weeks
Drug: Ulipristal
Patients undergoing surgery without any prior treatment, as control group
Daily single oral doses of 2 mg vilaprisan over 8-12 weeks
Daily single oral doses of 5 mg ulipristal over 8-12 weeks
The expression level of biomarker for glandular and stromal cell proliferation (Ki-67) in the endometrium of the same patient before treatment and when treated with VPR (vilaprisan) prior to surgery
Pre-treatment biopsy: The endometrial biopsy will be performed between Day 6 to 13 of the menstrual cycle that occurs after the screening visit and before treatment commences. Post-treatment biopsy as second endometrial biopsy is taken (if possible within 24 hours) after end of VPR treatment.
Time frame: From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
The expression level of biomarker for myoma cell proliferation (Ki-67) in fibroid tissue of patients not treated with PRM (progesterone receptor modulator )and those who have been treated with VPR prior to surgery
Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatment
Time frame: After maximum 12 weeks of treatment
The expression level of biomarkers for apoptotic regulation in the endometrium (BCL-2 (B-cell lymphoma 2), caspase 3) of the same patient before treatment and when treated with VPR prior to surgery
Pre-treatment biopsy: The endometrial biopsy will be performed between Day 6 to 13 of the menstrual cycle that occurs after the screening visit and before treatment commences. Post-treatment biopsy as second endometrial biopsy is taken (if possible within 24 hours) after end of VPR treatment
Time frame: From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
The expression level of biomarkers for apoptotic regulation in fibroid tissue (BCL-2, caspase 3) of patients not treated with PRM and those who have been treated with VPR prior to surgery
Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatment
Time frame: After maximum 12 weeks of treatment
The expression level of nuclear hormone receptors in the endometrium (progesterone receptor (PR), PR-B, estrogen receptor (ER), androgen receptor (AR)) of the same patient before treatment and when treated with VPR prior to surgery
Pre-treatment biopsy: The endometrial biopsy will be performed between Day 6 to 13 of the menstrual cycle that occurs after the screening visit and before treatment commences. Post-treatment biopsy as second endometrial biopsy is taken (if possible within 24 hours) after end of VPR treatment
Time frame: From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
The expression levels of biomarkers (Ki-67, caspase 3 and BCL-2) in the endometrium of the same patient before treatment and when treated with UPA prior to surgery
Pre-treatment biopsy: The endometrial biopsy will be performed between Day 6 to 13 of the menstrual cycle that occurs after the screening visit and before treatment commences. Post-treatment biopsy as second endometrial biopsy is taken (if possible within 24 hours) after end of treatment. Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of treatment
Time frame: From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
The expression levels of biomarkers (Ki-67, caspase 3 and BCL-2) in fibriod tissue of patients not treated with PRM and those who have been treated with UPA prior to surgery
Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatment
Time frame: After maximum 12 weeks of treatment
Ran from Nov 2017 to primary completion in Dec 2018, 13 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Vilaprisan